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• Avexitide significantly reduced serious low-blood-sugar events for patients who have undergone weight-loss surgery.
• The Phase 3 Lucidity trial enrolled 78 adults who developed post-bariatric hypoglycemia after a weight-loss surgery
• Amylyx plans to submit a New Drug Application with the FDA by the end of 2026.

Shares of Amylyx Pharmaceuticals (AMLX) surged more than 47% on Tuesday, after the biotech firm said its experimental drug Avexitide significantly reduced serious low-blood-sugar events for patients who have undergone a weight-loss surgery, setting the stage for a regulatory submission by the end of the year.

The positive results could potentially position Avexitide as the first approved treatment for post-bariatric hypoglycemia.

AMLX shares hit their highest levels since April 2023, and are on track to clock their biggest single-day gains in nearly four years.

Study Meets Primary And Secondary Goals

The Phase 3 Lucidity trial enrolled 78 adults who developed post-bariatric hypoglycemia after a weight-loss surgery. The condition occurs when the body releases too much insulin, causing blood sugar to potentially fall to dangerously low levels.

Participants received either a once-daily injection of Avexitide or a placebo for 16 weeks. Avexitide reduced the combined rate of Level 2 and Level 3 Hypoglycemic events by 55%, meeting the study’s U.S. Food and Drug Administration (FDA) agreed primary endpoint.

Level 2 events involve clinically significant low blood sugar, while Level 3 episodes are severe enough that patients may require help from another person. The study also met all its secondary endpoints, showing reductions across events measured through finger-stick tests, continuous glucose monitors and independent reviews.

The drug was generally well tolerated, with no treatment-related serious adverse events. The most common side effects included diarrhea, injection-site redness and bruising.

FDA Filing Planned By Year-End

Amylyx plans to submit a New Drug Application (NDA) with the FDA by the end of 2026. Avexitide already has Breakthrough Therapy and Orphan Drug designations.

The program has become particularly important after Amylyx withdrew its previous Amyotrophic lateral sclerosis (ALS) drug following a failed trial. Earlier this month, the company said its cash can fund operations into 2028, covering a possible Avexitide launch in 2027.

“Our NDA submission readiness is well underway, and we continue to advance our preparations for a potential commercial launch of Avexitide in 2027, if approved,” said Justin Klee and Joshua Cohen, Co-CEOs of Amylyx.

Retail Bulls Eye $100

Retail sentiment surrounding AMLX on Stocktwits flipped to ‘extremely bullish’ from ‘bearish’ over the past 24 hours, amid a 6,100% increase in message volumes. AMLX was also among the top trending tickers at the time of writing.

One user expects analysts to raise the stock’s price target.

Another user expects the stock to climb to $100. This is a potential upside of roughly 70% from current levels.

The stock has soared more than 151% so far this year.

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